Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT02175680 |
Recruitment Status :
Completed
First Posted : June 26, 2014
Last Update Posted : September 29, 2021
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This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Human Immunodeficiency Virus | Drug: PRO 140 350mg weekly SQ injection. | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | September 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
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Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist |
- Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ]
- Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ]
- Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 Weeks ]
- Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: 14 Weeks ]
- Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ]
- Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females, age ≥18 years
- Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
- On stable antiretroviral therapy for last 12 months
- Subject has two or more potential alternative antiretroviral regimen options to consider.
- No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit
- Nadir CD4 cell count of >200 cells/mm3
Exclusion Criteria:
- CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
- Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
- Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175680
United States, California | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Jacob Lalezari, MD |
Responsible Party: | CytoDyn, Inc. |
ClinicalTrials.gov Identifier: | NCT02175680 |
Other Study ID Numbers: |
PRO 140_CD 01 |
First Posted: | June 26, 2014 Key Record Dates |
Last Update Posted: | September 29, 2021 |
Last Verified: | September 2021 |
HIV-1 HIV Treatment Substitution PRO 140 |
PRO140 CytoDyn Amarex |
Acquired Immunodeficiency Syndrome HIV Infections Infections Immunologic Deficiency Syndromes Immune System Diseases Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Slow Virus Diseases Leronlimab HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |